D.R.E.A.M.S. will assess an immersive digital reality-augmenting system in reducing the occurrence of cognitive, behavioral, and emotional consequences of critical illness and environmental exposures that are risk factors for the development of delirium.
The purpose of Digital Rehabilitation Environment Augmenting Medical System (D.R.E.A.M.S.) is to research the feasibility and clinical potential of an immersive digital reality-augmenting system in reducing the occurrence of cognitive, behavioral, and emotional consequences of critical illness (e.g. pain, anxiety and insomnia) and environmental exposures (noise \& light) that are risk factors for the development of delirium, a common and devastating complication in the intensive care unit (ICU).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
100
Subjects will be guided through a mediation and relaxation exercise on a tablet or virtual reality headset for up to an hour each day.
UF Health
Gainesville, Florida, United States
Assessment of anxiety measured by Hospital Anxiety and Depression Scale (HADS) questionnaire
The assessment is used to gauge the subject's level of anxiety and depression 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)
Time frame: Immediately before and after each intervention Up to 7 days
Blood Pressure -Systolic
Alterations to vital signs allow for Non-Verbal Pain assessments
Time frame: Immediately before and after each intervention up to 7 days
Heart Rate
Alterations to vital signs allow for Non-Verbal Pain assessments
Time frame: Immediately before and after each intervention up to 7 days
Respiratory Rate
Alterations to vital signs allow for Non-Verbal Pain assessments
Time frame: Entire ICU stay up to 7 days
Patient pain perception
Defense and Veterans Pain Rating Scale (DVPRS) Likert Scale 0 - 10, with 10 = severe pain (as bad as it could be. nothing else matters)
Time frame: Immediately before and after each intervention up to 7 days
Amount of sedatives requested by subjects
Richmond Agitation-Sedation Scale (RASS)- Patients with a RASS of -3 or less should have their sedation decreased or modified in order to achieve a RASS of -2 to 0. Patients with a RASS of 2 to 4 are not sedated enough and should be assessed for pain, anxiety, or delirium. The underlying etiology of the agitation should be investigated and appropriately treated to achieve a RASS of -2 to 0.
Time frame: Entire ICU stay up to 7 days
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Amount of sedatives subjects receive
Richmond Agitation-Sedation Scale (RASS)- Patients with a RASS of -3 or less should have their sedation decreased or modified in order to achieve a RASS of -2 to 0. Patients with a RASS of 2 to 4 are not sedated enough and should be assessed for pain, anxiety, or delirium. The underlying etiology of the agitation should be investigated and appropriately treated to achieve a RASS of -2 to 0.
Time frame: Entire ICU stay up to 7 days
Subject's quality of sleep
Richards-Campbell Sleep Questionnaire (RCSQ) five-item, visual analogue scale was designed as an outcome measure for assessing the perception of sleep in critically ill patients. The scale evaluates perceptions of depth of sleep, sleep onset latency, number of awakenings, time spent awake, and overall sleep quality.
Time frame: Daily up to 14 days
DREAMS usability and acceptability questionnaire
A qualitative assessment of the usability and efficacy of the system Likert Scale 1-5, with 5 = strongly disagree.
Time frame: After each intervention up to 14 days